A Prediction Model of Anastomotic Stricture After Rectal Cancer

A Prediction Model of Anastomotic Stricture After Rectal Cancer: a Retrospective Cohort Analysis

Background: Anastomotic stricture significantly impacts patients' quality of life and long-term prognosis. However, current clinical practice lacks accurate tools for predicting anastomotic stricture. This study aimed to develop a nomogram to predict anastomotic stricture in patients with rectal cancer who have undergone anterior resection.

Methods: 1542 eligible patients will be recruited for the study. Least absolute shrinkage selection operator (Lasso) analysis will be used to preliminarily select predictors. A prediction model will be constructed using multivariate logistic regression and presented as a nomogram. The performance of the nomogram will be evaluated using receiver operating characteristic (ROC) curves, calibration diagrams, and decision curve analysis (DCA). Internal validation will be conducted by assessing the model's performance on a validation cohort.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Rectal Cancer; Anastomotic Stenosis
• Intervention / Treatment: Other: without any intervention

• Study Type: Observational
• Enrollment (Actual): 1542

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225000
      • Yifan Cheng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients who underwent anterior resection for rectal cancer at the Department of Gastrointestinal Surgery, Northern Jiangsu People's Hospital. All participants received radical treatment consistent with total mesorectal excision (TME) principles

Description

Inclusion Criteria:

1. pathological confirmation of rectal cancer;
2. eligibility for surgical intervention;
3. undergoing first rectal cancer surgery;
4. acquisition of written informed consent from patients and their families;
5. no history of hypertrophic scar or allergic predispositions.

Exclusion Criteria:

1. absence of postoperative follow-up or anastomosis details;
2. patients subjected to Hartmann or Miles procedures;
3. emergency surgery candidates due to conditions like perforation or obstruction;
4. diagnosis of multiple primary malignancies;
5. intraoperative discovery of widespread implant metastases within the abdominal cavity;
6. severe comorbidities;
7. anastomotic recurrence of rectal cancer;
8. patients who had undergone stapled hemorrhoidopexy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with anastomotic stricture; without any intervention, patients diagnose as anastomotic stricture after rectal cancer surgery	Other: without any intervention; without any intervention
patients without anastomotic stricture; without any intervention, patients does not diagnose as anastomotic stricture after rectal cancer surgery	Other: without any intervention; without any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patients with anastomotic stricture	Within six months after rectal cancer surgery, the patient was diagnosed with benign stricture of the rectal anastomosis	up to six months
patients without anastomotic stricture	Within six months after rectal cancer surgery, the patient was not diagnosed with benign stricture of the rectal anastomosis	up to six months

Collaborators and Investigators

• Sponsor: Northern Jiangsu People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: May 5, 2024
• First Submitted That Met QC Criteria: May 5, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 5, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: rectal cancer; nomogram; anastomotic stricture
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Constriction, Pathologic
• Other Study ID Numbers: NorthernJiangsu004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No